A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients (FLAT)

April 11, 2019 updated by: Qilu Hospital of Shandong University

A Multicentre Observational Study to Investigate the Improvement in Glucose FLuctuation of Sufficient Acarbose Therapy on Type 2 Diabetes Patient With High Blood Glucose Fluctuation

This is a multicentre observational study to investigate the improvement in glucose fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose fluctuation

Study Overview

Status

Recruiting

Conditions

Detailed Description

Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and thus effectively decreases postprandial blood glucose(PBG) as well as the risk of hypoglycemia before the next meal.Acarbose is now used as the preferred drug for some patients with prediabetes and newly diagnosed type 2 diabetes millitus(T2DM).This study aims to investigate the glycemic excursions with different courses and glycated hemoglobin A1c(HbA1c) levels after treated three months with acarbose.To minimize gastrointestinal side effects，starting dosage of acarbose of 50 mg is given orally three times daily for 10 days(with the first bite) of each main meal. Glycemic excursions are evaluated using the mean amplitude of glycemic excursions (MAGE), the postprandial glycemic excursions (PPGE) and the largest amplitude of glycemic excursions (LAGE).Freestyle Libre flash glucose monitoring system (FGMS，Abbott Laboratories,USA) was administered in this study. According to the standard Freestyle Libre Pro operating guidelines, the FGMS is installed in all participants to monitor glucose levels of interstitial fluid for 14 consecutive days. The glucose sensor is inserted into the subcutaneous tissue of upper arm at 8:00-9:00 in the morning.Glucose concentrations at 7 preset times per day (before meals, 2-h after meals and at bedtime) were determined with VivaChek Ino Smart（VivaChek Laboratories, Inc., USA) every two weeks.Four days before using acarbose and five weeks after using acarbose, FGMS was using to monitor the continuous glucose.MAGE was calculated for each subject by taking the arithmetic mean of FGM values increased or decreased (from nadirs to peaks or vice versa) when both ascending and descending segments exceeded the value of one standard deviation (SD) of the FGM values for 24-h period.The primary endpoint of the study is the extent of change in MAGE.Secondary endpoints are changes in PPGE,LAGE and HbA1c. Gene polymorphism is detected for enrolled patient with poor acarbose effect.

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

According to the course of diabetes, enrolled patients are divided into three groups: A (< 5Y), B (5-10y), C (> 10Y). According to the level of HbA1c,enrolled patients are divided into three groups:I (7%-8%), II (8%-9%), and III (9%-10%). Then there are nine groups, namely AI, AII, AIII, BI, BII, BIII, CI, CII, and CIII.100 patients are enrolled in each group.All enrolled patiens are 900.

Description

Inclusion Criteria:

  1. All enrolled patients sign the informed consent. sign the informed consent form.
  2. Clinical diagnosis of T2DM(1999 WHO).
  3. No acarbose in nearly 3 months.
  4. 7% < HbA1c ≤10% .
  5. PPGE >2.2mmol/L and LAGE >4.4mmol/L.
  6. MAGE > 3.9 mmol/L.
  7. The previous therapy remain the same.
  8. Contraception is needed for women of child-bearing age until 28 days after the end.

Exclusion Criteria:

  1. Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding.
  2. Replacement or chronic systemic corticosteroid therapy. Cytochrome P450 3A4 enzyme inducer or inhibitor therapy.Antiviral therapy for immunodeficiency disease.
  3. History of gastrointestinal disease or surgery including Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy, bariatric surgery or lap-band procedure.
  4. Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
  5. History of hemoglobinopathy .
  6. Any subject who was currently abusing alcohol or other drugs or had done so within the last 12 months.
  7. There are contraindications listed in the acarbose instructions.
  8. History of acute or chronic pancreatitis, or current acute or chronic pancreatitis.
  9. Type 1 diabetees mellitus.
  10. History of diabetic ketoacidosis or hyperosmolar nonketosis coma in recent 1 month.
  11. Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 3x upper limit of normal (ULN), or serum total bilirubin (TB) >34.2 μmol/L (>2 mg/dL).

  12. Patients with following renal disease history or renal disease related features:

    1. History of unstable or rapidly progressing renal disease;
    2. Patients with moderate /severe renal impairment or end-stage renal disease (eGFR< 60 mL/min/1.73 m2);
    3. Urinary albumin: creatinine ratio >1800 mg/g;
    4. Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124 μmol/L (≥1.40 mg/dL) for female subjects;
    5. Conditions of congenital renal glycosuria.

  13. Any of the following cardiovascular diseases within 6 months of the enrollment visit:

    1. Myocardial infarction;
    2. Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty);
    3. Unstable angina;
    4. Congestive heart failure New York Heart Association Class III or IV;
    5. Transient ischemic attack or significant cerebrovascular disease.
  14. Any subject , in the judgment of the investigator, was at risk that might affect the interpretation of efficacy or safety data or the conduct ion of the study，including laboratory and physical examination or ECG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extent of change in MAGE
Time Frame: 8 weeks
Mean absolute glucose excursions (MAGE) was calculated to assess intraday glucose variability. The difference between the consecutive peaks and nadirs exceeding one standard deviation (SD) of the daily mean blood glucose (MBG) level was expressed as absolute glucose excursion (AGE). MAGE was an arithmetic mean of all absolute AGEs.The average MAGE of the last three days of the eighth week are compared with the baseline（The average MAGE of the three days before using acarbose).The extent of change in MAGE is numerical value to to assess glucose variability.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extent of change in PPGE,LAGE
Time Frame: 8 weeks
Postprandial glucose excursion (PPGE) is calculated as the peak value of glucose after meals minus the glucose level at the beginning of each meal to evaluate the influence of meals on glucose fluctuation.Largest amplitude of glycemic excursions (LAGE) is calculated as the maximum minus the minimum blood glucose levels measured in one day.The average PPGE、LAGE of the last three days of the eighth week compared with the baseline（The average PPGE、LAGE of the three days before using acarbose）.
8 weeks
The control rate of HbA1c
Time Frame: 12 weeks
When HbA1c<7% was considered as the criteria, the control rate of HbA1c after 12 weeks.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene polymorphism
Time Frame: 12 weeks
Gene polymorphism is detected for enrolled patient with poor acarbose effect.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Bayer

Investigators

  • Principal Investigator: Lin Liao, MD, Qianfoshan Hospital
  • Principal Investigator: Yuping Zhou, MD, Weihai Municipal Hospital
  • Principal Investigator: Shuguang Pang, MD, Jinan Central Hospital
  • Principal Investigator: Fei Wang, MD, Huangdao Branch of Affiliated Hospital of Medical College,Qingdao University
  • Principal Investigator: Yongjun Jin, MD, Yantai Branch of Affiliated Binzhou Medical College
  • Principal Investigator: Tianying Xu, MD, People's Hospital of Qihe County
  • Principal Investigator: Guangzhen Zhang, MD, Liaocheng People's Hospital
  • Principal Investigator: Yunfeng Zhang, MD, Linyi lanshan district diabetes hospital
  • Principal Investigator: Lin Sun, MD, Affiliated Hospital of Jining Medical College
  • Principal Investigator: Dadong Fei, MD, Zaozhuang Municipal Hospital
  • Principal Investigator: Guangling Xu, MD, Guanxian people's hospital of liaocheng city

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 13, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-OI-1257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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